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The restor3d Outcomes Registry

30. april 2026 opdateret af: Restor3D

The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement

The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant. Using a master protocol framework, the study enrolls patients across multiple joint cohorts (knee, hip, foot & ankle, shoulder) under a single protocol, with joint-specific details governed by individual appendices. Participants self-enroll and complete electronic PRO surveys (ePROs) before surgery and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively, all remotely, with no required in-person visits. The study aims to quantify changes in pain, function, quality of life, and satisfaction over time, and to establish real-world outcome benchmarks for patient-specific orthopedic implants.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2000

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant and self-enroll via restor3d's patient engagement platforms or clinical research materials across the United States.

Beskrivelse

Master Protocol Inclusion Criteria:

  • Age ≥ 18 years
  • Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.

Master Protocol Exclusion Criteria:

  • Patient is receiving an implant not manufactured by restor3d
  • Patient is receiving a restor3d implant that is not FDA-cleared or approved
  • Patient lives outside the United States
  • Patient is receiving a restor3d implant that does not use a patient-specific plan, instrumentation or implant
  • Patient is non-English-speaking
  • Patient is receiving a restor3d implant outside of the defined implant cohorts
  • Patient does not provide informed consent
  • Plus additional cohort-specific exclusion criteria

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Knee Cohort
Adults who have received an FDA-cleared restor3d patient-specific knee implant (total knee replacement, unicompartmental knee replacement). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.
Enhed: Patient-Specific Orthopedic Implant
FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.
Hip Cohort
Adults who have received an FDA-cleared restor3d patient-specific hip implant. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.
Enhed: Patient-Specific Orthopedic Implant
FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.
Foot & Ankle Cohort
Adults who have received an FDA-cleared restor3d patient-specific ankle implant (total ankle replacement) or an FDA-approved restor3d patient-specific total talus replacement. Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.
Enhed: Patient-Specific Orthopedic Implant
FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.
Shoulder Cohort
Adults who have received an FDA-cleared restor3d patient-specific shoulder implant (reverse total shoulder arthroplasty). Participants complete ePRO surveys pre-operatively and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively.
Enhed: Patient-Specific Orthopedic Implant
FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Implant Survivorship (all cohorts)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Patient-reported implant survivorship as assessed through a sponsor-created post-market safety questionnaire, capturing implant-related adverse events including device malfunction, revision surgery, infection, wound complications, and life-threatening events.
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a score evaluated by comparing postoperative scores to baseline. Raw scores range from 6 to 30 on a 5-point Likert scale. Higher raw scores indicate greater severity of depressive symptoms.
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Hospital Stay (all cohorts)
Tidsramme: 6 weeks post-operatively
Length of hospital stay (in nights) via non-validated patient-reported outcome measure.
6 weeks post-operatively
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) evaluated by comparing postoperative scores to baseline. KOOS JR is a 7 item scale where items are originally rated on a 5-point Likert scale (0 to 4), creating a raw sum score (0-28), which is then converted into the 0-100 interval score. A higher score indicates better joint.
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Change in Ankle Osteoarthritis Scale (AOS) Score (Foot & Ankle cohort)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in Ankle Osteoarthritis Scale (AOS) evaluated by comparing postoperative scores to baseline. The AOS consists of 18 items divided into two subscales (9-item Pain subscale and 9-item Disability subscale), typically using a 100-mm Visual Analog Scale (VAS) for each answer. Higher scores indicate a worse condition, meaning more pain and greater disability
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Change in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) Score (Hip cohort)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) evaluated by comparing postoperative scores to baseline. The HOOS JR is a 6-item patient-reported survey used to evaluate hip health, with scores ranging from 0 to 100, which higher scores indicating better health.
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Change in Single Assessment Numeric Evaluation (SANE) score (Shoulder cohort)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in Single Assessment Numeric Evaluation (SANE) score evaluated by comparing postoperative scores to baseline. The SANE score is a patient-reported outcome measure where patients rate their shoulder on a 0-100% scale (100% being normal).
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Change in American Shoulder and Elbow Surgeons (ASES) score (Shoulder cohort)
Tidsramme: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)
Improvement in American Shoulder and Elbow Surgeons (ASES) score evaluated by comparing postoperative scores to baseline. The ASES score is a 100-point patient-reported outcome measure used to evaluate shoulder pain and function. It combines a 0-10 pain visual analog scale (weighted 50%) and 10 activities of daily living (ADL) questions (weighted 50%). Scores range from 0 (worst) to 100 (best).
Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Restor3D

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. maj 2026

Primær færdiggørelse (Anslået)

31. maj 2032

Studieafslutning (Anslået)

31. maj 2032

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • restor3d-011

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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